What is an investigational vaccine?
An investigational vaccine is one that is under study and is not approved by the U.S. Food and Drug Administration (FDA) for sale in the United States. Medical research studies are conducted to evaluate the safety and effectiveness of an investigational vaccine. These research studies are also called clinical trials. Once an investigational vaccine has been proven safe and effective in clinical trials, FDA may approve the vaccine for sale in the United States.
To learn more about investigational vaccines and investigational drugs, read the AIDSinfo What is an Investigational HIV Drug? fact sheet.
What is GTU-MultiHIV B?
GTU-MultiHIV B is an investigational vaccine that is being studied as a therapeutic vaccine for HIV.1 A therapeutic HIV vaccine is a type of vaccine that’s designed to improve the body’s immune response to HIV in a person who is already infected with HIV.3
HIV researchers are developing and testing therapeutic vaccines (1) to slow down the progression of HIV infection, (2) to eliminate the need for antiretroviral therapy (ART) while still keeping undetectable levels of HIV, and (3) as part of a combination strategy that includes HIV medicines and a therapeutic vaccine to eliminate all HIV from the body. (ART is the recommended treatment for HIV infection and involves using a combination of different HIV medicines to prevent HIV from replicating.) The AIDSinfo fact sheet What is a Therapeutic HIV Vaccine? has more information on therapeutic HIV vaccines.4,5
GTU-MultiHIV B is a DNA vaccine and is made up of parts of HIV’s genetic information. The HIV genetic information is meant to produce an immune response against HIV in the body. Besides being studied as a therapeutic HIV vaccine, GTU-MultiHIV B is also being investigated to see if it can prevent HIV infection in people who do not have the virus.1,4 This vaccine record focuses on the study of GTU-MultiHIV B as a therapeutic vaccine.
How are clinical trials of investigational vaccines conducted?
Clinical trials are conducted in phases. Each phase has a different purpose and helps researchers answer different questions.6
- Phase I trials: Researchers test an investigational vaccine in a small group of people (20–80) for the first time. The purpose is to evaluate its safety, identify side effects, and determine if the vaccine produces an immune response in the body.
- Phase II trials: The investigational vaccine is administered to a larger group of people (100–300). Researchers further evaluate the vaccine’s safety and ability to produce an immune response in the body. Some effectiveness data on the health benefits of the vaccine may also be collected.
- Phase III trials: The investigational vaccine is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments, and collect information that will allow the investigational vaccine to be used safely.6,7
In most cases, an investigational vaccine must be proven effective and must show continued safety in a Phase III clinical trial
to be considered for approval by FDA for sale in the United States. Some vaccines go through FDA’s accelerated approval process and are approved before a Phase III clinical trial is complete. After a vaccine is approved by FDA and made available to the public, researchers track its safety in Phase IV trials
to seek more information about the vaccine’s risks, benefits, and optimal use.6
(Some clinical trials are categorized as “a” or “b,” such as “Phase Ia” or “Phase IIb.” These different subphases typically mean that a study is researching certain types of information or using a certain type of participant population.)
In what phase of testing is GTU-MultiHIV B?
As a therapeutic HIV vaccine, GTU-MultiHIV B is currently being studied in a Phase II clinical trial.1
What are some studies on GTU-MultiHIV B?
GTU-MultiHIV B therapeutic vaccine
Study Names: CUT*HIVTHER 001; NCT02457689
Sponsor: Imperial College London
Location: United Kingdom
- Participants are HIV-infected adults who have subtype B HIV and are receiving ART.
- While on ART, participants have had viral load levels of less than 200 copies/mL at 2 separate times in the past 6 months. (Viral load is the amount of HIV in a blood sample.)
- At screening, participants have CD4 counts higher than 200 cells/mm3. Prior to screening, a participant’s lowest CD4 count was higher than 250 cells/mm3. (A CD4 count is a laboratory test that measures the number of CD4 cells—a type of immune cell—in a sample of blood and is an important indicator of immune function.)
Purpose: The purpose of this study is to look at GTU-MultiHIV B vaccine’s safety and ability to produce an immune response in the body when GTU-MultiHIV B is given by 2 different methods.8
* This study is currently recruiting participants.
Study Names: ANRS 149 LIGHT; NCT01492985
Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
- Participants are HIV-infected adults with no symptoms of HIV infection who have been on ART for at least 18 months.
- Participants have had viral load levels of less than 50 copies/mL for the past 6 months and at screening.
- Participants have had CD4 counts of at least 600 cells/mm3 for the previous 6 months and at screening. A participant’s lowest CD4 count while on ART was 300 cells/mm3 or higher.
Purpose: The purpose of this study is to find out whether a combination of GTU-MultiHIV B and another investigational therapeutic vaccine called LIPO-5 can produce an immune response in the body that controls viral load levels after treatment interruption.9 (A treatment interruption is a planned break from HIV medicines to evaluate how well an investigational drug can maintain control of a participant’s viral load during a clinical trial.)
Study Names: FIT-06; EudraCT 2005-003071-20
Sponsor: FIT Biotech Oyj Plc
Location: South Africa
- Participants were HIV-infected adults with subtype C HIV who had been chronically infected with HIV. (Chronic HIV infection is the second stage of HIV infection and occurs after several months of infection. This stage can last for many years.) Participants had never taken ART before (called treatment-naive).
- Participants had viral load levels of at least 50 copies/mL and CD4 counts of at least 350 cells/mm3.
: The purpose of this study was to look at GTU-Multi HIV B vaccine’s safety and ability to produce an immune response in the body when GTU-Multi HIV B was given by 2 different injection methods. Investigators also evaluated if the vaccine had any beneficial effects on participants’ viral load levels and CD4 counts.10,11
A Phase I study (NCT01130376
) involving GTU-MultiHIV B given in combination with immune modulators in participants on a suppressive ART regimen has also been completed. (A suppressive ART regimen describes ART that is controlling a person’s viral load to an undetectable level. Immune modulators are substances that modify the functioning of the immune system.)12,13
For more details on the studies listed above, see the Health Professional version
What side effects might GTU-MultiHIV B cause?
Early data from the ANRS 149 LIGHT study (NCT01492985) was reported in a press release from the GTU-MultiHIV B manufacturers. The data suggest that no major side effects occurred in the participants receiving GTU-MultiHIV B and LIPO-5.10
In the FIT-06 study, there were no serious side effects related to GTU-MultiHIV B. Local vaccine reactions that occurred immediately or 30 minutes after injections were mild to moderate in severity and were seen more often in participants receiving the intradermal injection than in participants receiving the intramuscular injection. Examples of local vaccine reactions that occurred include bleeding at the injection site and localized swelling and hardening of tissue. Other side effects that occurred in participants receiving GTU-MultiHV B and participants receiving placebo included swelling of lymph nodes, upper respiratory tract infections, and increased blood levels of creatine phosphokinase (an enzyme that’s normally found in the heart, brain, and skeletal muscles).10,11,15
Because GTU-MultiHIV B is still being studied, information on possible side effects of the vaccine is not complete. As testing of GTU-MultiHIV B continues, additional information on possible side effects will be gathered.
Where can I get more information about clinical trials studying GTU-MultiHIV B?
More information about research studies related to GTU-MultiHIV B is available from the AIDSinfo database of ClinicalTrials.gov study summaries. Click on the title of any trial in the list to see the ClinicalTrials.gov trial summary and more information about the study.
How can I find more information about participating in a clinical trial?
Participating in a clinical trial can provide benefits. For example, a volunteer participant can benefit from new research treatments before they are widely available. Participants also receive regular and careful medical attention from a research team that includes doctors and other health professionals. However, clinical trials may also involve risks of varying degrees, such as unpleasant, serious, or even life-threatening side effects from the treatment being studied.6
Your health care provider can help you decide whether participating in a clinical trial is right for you. For more information, visit NIH Clinical Research Trials and You.
- Clayden P, Collins S, Frick M, et al. HIV i-BASE/Treatment Action Group. 2016 Pipeline Report. July 2016. Available at: http://www.pipelinereport.org/sites/default/files/2016%20Pipeline%20Report%20Full_0.pdf. Last accessed on November 2, 2016.
- Ensoli B, Cafaro A, Monini P, Marcotullio S, Ensoli F. Challenges in HIV Vaccine Research for Treatment and Prevention. Front Immunol. 2014; 5: 417. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157563/. Last accessed on November 2, 2016.
- The History of Vaccines website. The Development of HIV Vaccines. Available at: http://www.historyofvaccines.org/content/articles/development-hiv-vaccines. Last accessed on November 2, 2016.
- Smith PL, Tanner H, Dalgleish A. Developments in HIV-1 immunotherapy and therapeutic vaccination. F1000Prime Rep. 2014 Jun 2; 6:43. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4047951/. Last accessed on November 2, 2016.
- Graziani GM and Angel JB. Evaluating the efficacy of therapeutic HIV vaccines through analytical treatment interruptions. J Int AIDS Soc. 2015; 18(1): 20497. Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4641978/. Last accessed on November 2, 2016.
- National Institutes of Health (NIH). NIH Clinical Research Trials and You. Available at: https://www.nih.gov/health-information/nih-clinical-research-trials-you. Last accessed on November 2, 2016.
- Hudgens MG, Gilbert PB, Self SG. Endpoints in vaccine trials. Stat Methods Med Res. 2004; 13: 1-26. Available at: http://faculty.washington.edu/peterg/Vaccine2006/articles/HudgensGilbertSelfSMMR.pdf. Last accessed on November 2, 2016.
- Imperial College London. A Randomized Phase I/II Study to Assess the Safety and Immunogenicity of the DNA-GTU Vaccine Administered by Two Novel Routes Compared to Placebo in HIV-infected Patients on Antiretroviral Therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 27, 2015. NLM Identifier: NCT02457689. Available at: https://clinicaltrials.gov/ct2/show/NCT02457689. Last accessed on November 2, 2016.
- French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS). Evaluation of a Therapeutic Immunization Strategy Associating a DNA Vaccine (GTU-MultiHIV B) Followed by a Lipopeptide Vaccine (LIPO-5) in the Control of Viral Replication Following Antiretroviral Treatment Interruption in HIV-1 Infected Patients With a CD4 Cell Count ≥ 600/mm3. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on November 24, 2011. NLM Identifier: NCT01492985. Available at: https://clinicaltrials.gov/ct2/show/NCT01492985. Last accessed on November 2, 2016.
- Vardas E, Stanescu I, Leinonen M, et al. Indicators of therapeutic effect in FIT-06, a Phase II trial of a DNA vaccine, GTU(®)-Multi-HIVB, in untreated HIV-1 infected subjects. Vaccine. 2012 Jun 8; 30(27): 4046-54. Available at: https://www.ncbi.nlm.nih.gov/pubmed/22549090. Last accessed on November 2, 2016.
- Vardas E, Stanescu I, Leinonen M, et al. Indicators of therapeutic effect in FIT-06: A Phase II Trial of a DNA vaccine GTU®-MultiHIV, in untreated HIV-1 infected participants. Slides presented at: AIDS Vaccine 2010; September 28 – October 1, 2010; Atlanta, GA. Available at: http://www.vaccineenterprise.org/conference_archive/2010/pdf-presentations/Wednesday/Oral-Abstract-01/VardasE.pdf. Last accessed on November 2, 2016.
- Imperial College London. A Randomised, Open Labelled, Phase I, Safety, Toxicity, and Exploratory Immunogenicity Evaluation of Therapeutic Immunisation +/- IL-2, GM-CSF and Growth Hormone in HIV-1 Infected Subjects Receiving Highly Active Anti-retroviral Therapy. In: ClinicalTrials.gov. Bethesda (MD): National Library of Medicine (US). Registered on May 25, 2010. NLM Identifier: NCT01130376. Available at: https://clinicaltrials.gov/ct2/show/NCT01130376. Last accessed on November 2, 2016.
- Herasimtschuk A, Downey J, Nelson M, et al. Therapeutic immunisation plus cytokine and hormone therapy improves CD4 T-cell counts, restores anti-HIV-1 responses and reduces immune activation in treated chronic HIV-1 infection. Vaccine. 2014 Dec 5; 32(51): 7005-13. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25454870. Last accessed on November 2, 2016.
- FIT Biotech Oy: Press Release, dated June 9, 2016. FIT Biotech’s HIV vaccine demonstrated to be safe and well tolerated in two clinical studies. Available at: http://www.fitbiotech.com/tiedote/fit-biotech-oy-fit-biotechs-hiv-vaccine-demonstrated-to-be-safe-and-well-tolerated-in-two-clinical-studies/. Last accessed on November 2, 2016.
- Vardas E, Stanescu I, Valtavaara M, et al. Indicators of therapeutic vaccine effect using GTU-MultiHIV B clade DNA in treatment-naïve subtype C HIV-1 infected subjects. Abstract presented at: 18th International AIDS Conference (IAC); July 18-23, 2010; Vienna, Austria. Abstract MOPDB102. Available at: http://www.abstract-archive.org/Abstract/Share/1945. Last accessed on November 2, 2016.
Last Reviewed: November 2, 2016